Sterilization Facility Closures Could Mean Medical Device Shortages

By Kelly Young

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA is warning that closures of several sterilization facilities in the U.S. could mean limited availability of certain medical devices.

Three facilities that sterilize medical devices with the gas ethylene oxide have either closed or are threatening to close because of emissions violations. Ethylene oxide is considered a carcinogen.

Sterilization with ethylene oxide accounts for about half of medical device sterilizations in the U.S.

In a statement, Acting FDA Commissioner Ned Sharpless said: "Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of ... critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices. It's important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices."

The FDA says they are examining alternatives to the current sterilization procedures.